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Patient Blood Management In CARdiac sUrgical patientS

Patient Blood Management In CARdiac sUrgical patientS: the ICARUS Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04744181
Acronym
ICARUS
Enrollment
479
Registered
2021-02-08
Start date
2021-01-18
Completion date
2022-01-31
Last updated
2025-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Blood Loss Anemia, Erythropoiesis Abnormal, Iron-deficiency, Iron Deficiency Anemia, Iron Deficiency Anemia Treatment

Brief summary

Nowadays up to 40% of patients undergoing cardiac surgery receives at least 1 unit of red blood cell transfusion during surgery or during the first week after surgery. Moreover up to 40% of these patients shows an absolute or relative iron deficiency, with or without anaemia. The objective of this study is to assess whether to implement an adequate correction of iron according to current patients blood management recommendations might reduce RBC transfusion requirements in patients undergoing heart surgery. Data obtained in patients included in the study will be compared to those of a case-control population selected from patients consecutively treated at the same department in the previous 2 years.

Detailed description

Anemia is defined by the World Health Organization (WHO) as a value of hemoglobin (Hb) \< 130 g/L in men and \< 120 g/L in women. Anemia in surgical patients is a common and serious problem, in fact up to 40% of patients presenting for major surgery are anemic. Patients with pre-operative anemia have significantly higher rates of morbidity and mortality and are likely to receive red blood cell (RBC) transfusions. In turn, RBC are independently associated with worse outcome. Preoperative anemia mainly results from inadequate erythropoiesis owing to iron deficiency. Iron deficiency anemia (IDA) has a complex origin, including either absolute or functional iron deficiency (or iron sequestration). In absolute iron deficiency, iron stores are severely decreased, resulting in anaemia (IDA). Conversely, functional iron deficiency refers to insufficient iron mobilization despite normal or elevated iron stores (iron deficient erythropoiesis, IDE).The most rapid and simple method to correct anaemia is RBC transfusion. More than 30% of cardiac patients receives blood products in the peri-operative phase. However, blood transfusion itself is not without risk: in the setting of cardiac patients, even a single unit of blood transfused is reported to be associated to increased morbidity and mortality. Specifically, blood transfusions in cardiac surgery are associated with infections, ischemic postoperative morbidity, hospital stay, increased early and late mortality, and greater hospital costs. Preoperative correction of iron deficiency, with or without anaemia, is an integral part of the concept of the Patient Blood Management (PBM). Iron supplementation would increase the availability of iron stores and would trigger the process of erythropoiesis; the consequent relative lack of vitamin B12 and folic acid makes fundamental to restore also these 2 vitamins. The objective of this study is to assess whether to implement an adequate correction of IDA and IDE according to current PBM recommendations might reduce RBC transfusion requirements in patients undergoing heart surgery. Data obtained in patients included in the study will be compared to those of a case-control population selected from patients consecutively treated at the same department in the previous 2 years.

Interventions

DRUGFerric carboxymaltose

administration of a single dose of ferric carboxymaltose in those patietns who fulfill the inclusion criteria

DRUGB vitamin

administration of a single dose of B vitamin in those patietns who fulfill the inclusion criteria

DRUGFolic acid

administration of a single dose of folic acid in those patietns who fulfill the inclusion criteria

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

\- all adult patients candidate to planned heart surgery

Exclusion criteria

* Pregnancy * Know allergy to iron, or B vitamin, or folic acid * Hyperferritinemia (ferritin blood value \> 300 ng/ml). * patient's refusal

Design outcomes

Primary

MeasureTime frameDescription
Percentage of patients receiving RBC transfusion within post-operative day 7within post operative day 7Percentage of patients receiving RBC transfusion within post-operative day 7

Secondary

MeasureTime frameDescription
Hb values at last postoperative control within 7 days from surgerywithin post operative day 7Hb values at last postoperative control within 7 days from surgery
length of stay in ICUthrough study completion, an average of 1 yearlength of stay in ICU
number of allogeneic blood products administeredwithin the first 7 days post operativenumber of allogeneic blood products administered
duration of mechanical ventilationwithin the first 7 days post operativeduration of mechanical ventilation
serious adverse eventswithin the first 12 hours after administrationincluding hypersensitivity reactions
infections requiring antibiotic treatmentwithin the first 7 days post operativeinfections requiring antibiotic treatment
mortalitywithin the first 7 days after surgerypatients died within the first 7 days after surgery
major adverse cardiac and cerebrovascular eventswithin the first 7 days after surgerycardiogenic shock, neurological events
cost for the IDA/IDE treatment and blood product costswithin the first 7 days after surgerycost for the IDA/IDE treatment and blood product costs
acute kidney injurywithin the first 7 days post operativeworsening of renal function

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026